In the early beginnings of medical device packaging, the package was considered to be secondary to the product itself. Any testing that occurred was generally at the sole discretion of the medical device manufacturer.

 

However, as recalls began to impact the medical device industry in the latter half of the 20th century, the industry began to adopt some test techniques. Here is a brief look at the past, present, and the future with regard to the optimization of Australian packaging standards and package testing practices.

 

The Origins of Package Testing


Modern package testing standards for medical devices in Australia dates back more than 30 years ago to the passage of the Therapeutic Goods Act in 1989. The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia.

 

The requirement to protect therapeutic goods to be imported, supplied or exported so that they meet applicable standards, defined the need for process control and concern about maintaining barrier sterility. This, along with research that was occurring in the United States, lead to the first awareness of the fact that package testing must involve both seal-strength testing and package integrity testing.

 

As industry groups in the United States, including HIMA and AAMI began to explore the medical packaging and testing from a scientific perspective, new research arose that resulted in a major industry study. The study, an MD&DI in August and September 1995 (“In Quest of Sterile Packaging”), resulted in a shift of opinion among U.S. device manufacturers and testing professionals that whole-package microbial challenge tests were not the solution.

 

Instead, physical integrity test methods were determined to provide a more reliable measure of package sterility. The work of these industry groups and regulatory bodies in the United States, including the FDA, also contributed to the need for international standardization in other countries, including Australia. These events also played a key role in the establishment of the ASTM International’s flexible medical package subcommittee.

 

Modern Package Testing


As a result, modern leak testing equipment is rigorously defined and evaluated quantitatively before it is ever used by manufacturers. As the focus has shifted towards performance, medical device manufacturers have become increasingly reliant upon highly specialized and sophisticated test equipment companies, like Sealtick.

 

The Future of Package Testing Practices


Although physical testing has not changed much in the past few decades with regard to its philosophy, new research is likely to come along that will enable test designers to create equipment that not only ensures that test methods are accurate, sensitive, and repeatable, but are also highly adapted to the products being tested.

As a result, market leaders like Sealtick will continue to devote our time and company resources to evaluate new test methods and instruments with international standards in mind. To learn more about the products that we offer, contact us at 03 9540 5100 or via email at sealtick@bestech.com.au.